Simulations Plus and the University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables

Simulations Plus, Inc. (Nasdaq: SLP) ("Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced that it has been awarded a newly funded grant from the U.S. Food and Drug Administration (FDA) to use physiologically based pharmacokinetic (PBPK) approaches in GastroPlus® to build and validate mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) technologies through a joint proposal with the University of Connecticut’s School of Pharmacy, Department of Pharmaceutical Sciences.

This project aims to use the GastroPlus PBPK platform to investigate the intricate relationship between LAI formulation critical quality attributes (CQAs) and physiological factors at the injection site to accurately predict in vivo drug release and absorption. Dr. Diane Burgess, Board of Trustees Distinguished Professor of Pharmaceutics and Pfizer Distinguished Endowed Chair of Pharmaceutical Technology at the University of Connecticut and her lab will generate in vitro and in vivo data for marketed LAI suspension products using novel discriminatory systems. The scientific team at Simulations Plus will use this data, along with additional inputs from research collaborators, to develop PBPK models and apply them to validate mechanistic IVIVCs. This effort is expected to lay the groundwork for a practical alternative to in vivo studies in establishing bioequivalence (BE) for additional LAI product technologies.

"LAI formulations are becoming increasingly important in pharmaceutical pipelines and product portfolios due to their ability to improve patient compliance and deliver extended drug release,” said Dr. Daniela Silva Ryan, Scientist II at Simulations Plus and principal investigator for this grant. "Preclinical and clinical studies to evaluate new formulation designs are lengthy and expensive. With this new grant, we expect our work within GastroPlus to demonstrate how PBPK modeling can reduce development time and costs, while streamlining regulatory processes for both innovator and generic formulations.”

FDA scientific and program staff will actively collaborate with the University of Connecticut, Simulations Plus, and select industry partners. Dr. Silva Ryan, with assistance from scientists at Simulations Plus, will coordinate the contract’s modeling and simulation activities.

"It is a privilege to continue combining our expertise with Simulations Plus and the FDA to advance the research on LAI formulation performance even further,” added Dr. Burgess. "The agency’s trust and confidence in this partnership underscores the leadership role both organizations have in our respective spaces. Together, we aim to develop models that bridge the gap between animal and human data and reveal the intricate relationships between formulation properties and injection site physiology, providing insight into virtual BE approaches for this growing drug delivery technology.”

Funding for this collaboration is made possible by the FDA through grant award 1U01FD008304-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organizations imply endorsement by the United States Government.

About the Burgess laboratory at the University of Connecticut

The Burgess laboratory in the Department of Pharmaceutical Sciences at the University of Connecticut’s School of Pharmacy has a research focus on formulation science, drug delivery and manufacturing science of complex parenterals. Research efforts cover the basic science of interfacial chemistry, the application of this in preformulation and formulation development, the development of novel drug delivery systems, and the in vitro and in vivo testing of these drug delivery systems including investigation of biopharmaceutics and pharmacodynamics. This research is applied to solving problems with respect to drug and gene delivery and focuses on microsphere, nanoparticle, liposome, emulsion, hydrogel and in situ forming delivery systems. Efforts are also focused on biocompatible coatings to prevent the foreign body reaction that would otherwise result in loss of functionality of parenteral implantable devices.

Major contributions include: development of novel microcapsule dosage forms; development of "real-time” and accelerated performance tests for complex parenteral dosage forms and development of IVIVCs for these complex dosage forms; modeling of the pharmacokinetics of protein therapeutics from microsphere dosage forms; correlation of interfacial properties with emulsion and nanoparticle stability; development of a novel composite coating for implantable devices that has been shown to prevent the foreign body response in animal models in excess of 6 months; development of a method that allows long-term intracellular and intranuclear tracking of gene therapeutics and gene delivery vectors; design of safe, efficient and stable non-viral gene delivery systems; application of quality-by-design principles to nanoparticles and liposomes; and development of novel manufacturing methods for liposomes and emulsions, including the development of continuous manufacturing methods with process analytical technology for complex parenterals such as liposomes, lipid nanoparticles (LNPs)

About Simulations Plus, Inc.

With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube.

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